Admitting that there is pressure from big pharma companies to change the Indian patent law, the Arun Maira-led high-level committee on ?FDI policy in Indian pharma sector? has warned against giving in to their demands on data exclusivity and scrapping Section 3(D) of the Indian Patent Act. Section 3(D), when read with other provisions of the patent law, states that a new form of a known medicine can only be patented if it is not obvious and shows significantly improved therapeutic efficacy over existing medicines.
The committee acknowledges that prices of medicines have shot up in those countries where such IPR principles ? advocated by innovator pharma companies, mostly from the US ? have been introduced. This, the committee concludes, is indicated by an increasing body of evidence worldwide.
“Therefore, a valid case is made for India not to succumb to pressure from these pharma companies and Western governments, to go beyond the IPR agreements it has already entered into. Currently, we are under pressure to concede on date exclusivity, ?evergreening?, Clause 3(D), which we should not,” notes the Maira committee.
Pharma MNCs have been lobbying with various government arms to do away with Section 3(D), which according to them, stifles incentives to innovate by preventing patent grants to incremental pharma innovation. Domestic pharma companies and public health groups, on the other hand, have fought tooth and nail to keep these demands of research-based multinational pharma firms out of India’s commitments, most recently in the EU-India free trade agreement (FTA) text.
“We totally agree with this observation of the Maira committee. This has also been the stated position of the government of India as the PM’s office has clarified that India would not yield to anything more in the IPR domain than what it has already committed to under WTO and TRIPs, in the very context of EU-India FTA,” said DG Shah, secretary general, Indian Pharma Alliance, a domestic pharma industry association.
“The report is right in cautioning the government against undertaking TRIPS plus IP obligations, such as data exclusivity. Such obligations must be undertaken only when there is clear evidence that increased protection would be beneficial for India. As of today, we do not have any empirical evidence supporting a case for data exclusivity. Even if we introduce it, me must use it as a tool to foster more local clinical trials and compensate only these costs and not the global R&D costs, which are anyway recovered many fold through sales in developed markets,” said IP expert Shamnad Basheer.
The committee notes that as the cost of developing new drugs is moving north globally, there is pressure from the research-based pharma multinationals for changes in rules (Indian patent law) to extend their monopolies on products so that they can recover their investments on drug development.
Data exclusivity provisions would prevent India?s drug regulator from referring to the registration data previously filed by innovator drug companies while granting approval to therapeutically equivalent generic versions during the period of exclusivity. By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining marketing licence for cheaper generic drugs during the tenure of this exclusivity as the generic firms would be forced to repeat time-consuming, expensive, clinical studies before they apply for regulatory approval for a generic version of a drug.